The state of medical devices in accordance with the degree of risk to implement the management of classification. There are three main categories of medical devices:
The first category is low-risk, routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.
Medical devices as an important part of the pharmaceutical industry, for consumers, medical institutions in the configuration of medical machinery is second only to the physician equipped with the standard used to judge the medical institutions. The state for the development of medical equipment industry is also devoted a lot of effort, but to date, China's medical equipment industry in the field of high-end products, the competitiveness of local enterprises is still unbeatable.
Expanded InformationIn one of the following cases, the food and drug supervision and management department of the people's government at or above the county level shall confiscate the illegal income, illegal production and operation of medical devices and tools, equipment, raw materials and other items used in the illegal production and operation;
The value of the illegal production and operation of medical devices is less than 10,000 yuan and impose a fine of 50,000 yuan or more than 100,000 yuan; the value of the value of 1 million yuan or more, and impose a fine of 50,000 yuan or more than 100,000 yuan. More than 10,000 yuan, and impose a value of more than 10 times the amount of 20 times the amount of fine; the circumstances are serious, within five years will not be accepted by the relevant responsible person and the enterprise to apply for a medical device license:
(a) the production and operation of medical devices without obtaining the registration certificate for medical devices of the second, third class medical devices;
(b) unauthorized to engage in the production of the second, third class medical devices;
(c) illegal production of medical devices, equipment, raw materials and other items;
It is not possible to obtain a registration certificate for medical devices. /p>
(C) unauthorized to engage in Class III medical device business activities.
The first paragraph of the preceding circumstances, the circumstances are serious, by the original licensing department to revoke the medical device manufacturing license or medical device license.
Baidu Encyclopedia-Medical Equipment